BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOLLOS

    MDR report key: 14350543 · Received May 10, 2022

    Report

    Report Number
    3008406502-2022-00002
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    February 4, 2022
    Report Date
    May 10, 2022
    Manufacturer
    TOLLOS, INC.
    Product Code
    FSA
    UDI-DI
    00817956021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER WAS NOTIFIED OF THE EVENT THAT INVOLVED THE IDENTIFIED DEVICE, INCLUDING THE PROBLEM EXPERIENCED. HOWEVER; NO OTHER INFORMAITON WAS PROVIDED. INITIALLY, THE FACILITY/USER DID NOT RESPOND TO REQUESTES TO COME ON-SITE TO EVALUTE THE DEVICE, BUT ON (B)(6) 2022, THE FACILITY CALLED AND ASKED FOR SOMEONE FROM THE MANUFACTURING COMPANY TO COME AND INSPECT. INSPECTION, AND THE BEGINNING OF RCA WILL BEGIN ON MAY 12. MORE INFORMAITON SHOULD BE AVAILABLE AFTER THAT TIME.

    Description of Event or Problem · 0

    FROM THE USER MEDWATCH 3500 FORM (THIS INFORMAITON WAS NOT PROVIDED DIRECTLY TO THE MANUFACTURER): THE CEILING LIFT STRAP BROKE WHEN THE PATIENT WAS BEING TRANSFERRED OUT OF BED TO THE WHEELCHAIR VIA LIFT. THE PATIENT FELL APPROXIMATELY 3 FEET TO THE FLOOR, LANDING ON HIS RIGHT SIDE. THE NURSING SUPERVISOR WAS NOTIFIED AND BROUGHT A HOVER MAT TO ASSIST THE PATIENT BACK INTO THE BED. THE NURSE PRACTITIONER WAS NOTIFIED AND PRESENTED TO ASSESS THE PATIENT BEFORE HE WAS TRANFERRED BACK INTO THE BED. FROM MANUFACTURER: PLEASE NOTE THAT THE FACILITY DID NOT PROVIDE TOLLS WITH ANY INFORMATION RELATED TO THE EVENT OF THE PATIENT. THE BIRTHDATE AND THE AGE ARE JUST PLACEHOLDERS TO ALLOW SUBMISSION OF THIS MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2276971 TOLLOS PATIENT LIFT (CEILING LIFT) FSA TOLLOS, INC. CIRRUS 750 00817956021

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Prefer Not To Disclose